Regional Allergies Great Lakes U.s.
FDA Label NDC 57955-0752

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by King Bio Inc. for the product Regional Allergies Great Lakes U.s. (NDC 57955-0752). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, other safety information, inactive ingredient, otc - purpose, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Drug Facts​__________________________________________________________________________________________________________

HPUS active ingredients: ​Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin(30X), Allium cepa, Ambrosia artemisiaefolia, Chelidonium majus, Chenopodium vulvaria, Cichorium intybus, Cortisone aceticum, Euphrasia officinalis, Galphimia glauca, Hedera helix, Histaminum hydrochloricum, Juglans cinerea, Kali muriaticum, Mucosa nasalis suis, Natrum muriaticum, Pulsatilla, RNA, Sabadilla, Teucrium scorodonia.

Indications & Usage

Uses for temporary relief of allergy symptoms commonly experienced in IA, IL, IN, MI, MN, MO, OH, WI: •itchy, watery eyes •runny nose •sneezing •sore throat •sinus congestion •cough •stuffy nose •fatigue •itchy, irritated skin •hoarseness •headache.

† as per various homeopathic materia medicas. These uses have not been evaluated by the FDA, and product has not been clinically tested.

Warnings

Warnings

  • If symptoms persist more than seven days or worsen, consult a physician.
  • If pregnant or breast-feeding, ask a healthcare professional before use.

Otc - Keep Out Of Reach Of Children

  • Keep out of reach of children.

Dosage & Administration

Directions

  • Initially, depress pump until primed.
  • Spray one dose directly into mouth.
  • Adults: 3 sprays 3 times per day.
  • Children ages 6-12: 2 sprays 3 times per day.
  • Use addittionlly as needed, up to 6 times per day.

Other Safety Information

Other information: Tamper resistant for your protection. Use only if safety seal is intact.

Inactive Ingredient

Inactive Ingredients:

Bio-Energetically Enhanced™ pure water, Carya ovata bark extract (hickory), citrus extract, Lonicera japonica (honeysuckle), polylysine (natural ferment), steviol glycosides (stevia).

Otc - Purpose

Drug Facts

____________________________________________________________________________________________________________

HPUS* active ingredients                                      Purpose

Equal volumes of each ingredient in 12X, 30X, and 1LM potencies.

Adenosinum cyclophosphoricum.........................headache, runny nose

Adrenalinum.......................hay fever, swollen sinuses, lung congestion

Adrenocorticotrophin (30X).....................................congestion, cough

Allium cepa..................................hay fever, sinus headache, sneezing

Ambrosia artemisiaefolia................................hay fever, wheezy cough

Chelidonium majus.............................mucus in eyes, spasmodic cough

Chenopodium vulvaria....................restlessness, left-side head pressure

Cichorium intybus................................fatigue, headache, eye irritation

Cortisone aceticum......................................allergic reaction, irritability

Euphrasia officinalis................................discharge from eyes and nose

Galphimia glauca..........................................swollen eyelids, hay fever

Hedera helix........................catarrhal inflammation, cough with sputum

Histaminum hydrochloricum........................coughing fits, itching throat

Juglans cinerea..........................red, swollen eyes, sneezing, sore throat

Kali muriaticum...............................hoarseness, stuffy nose, nosebleed

Mucosa nasalis suis...........................sinus headache, nasal congestion

Natrum muriaticum............................................watery eyes, sneezing

Pulsatilla...................................pain in head and eyes, mucus in throat

RNA.......................................................................allergiec reactions

Sabadilla......................................sore throat, runny nose, sneezing fits

Teucrium scorodonia....................bronchial congestion with much mucus

"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopeia of the united States.

* Please review the disclaimer below.